Revoked Bamlanivimab EUA Status When Administered Alone
April 16, 2021
Therapeutics Update
The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our
full list of updates.
The Office of the Assistant Secretary for Preparedness and Response (ASPR) remains committed to ensuring our stakeholders receive timely and transparent communication regarding monoclonal antibody treatments currently authorized for emergency use in certain patients for the treatment of COVID-19.
Today (4/16/2021), the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for bamlanivimab, when administered alone, to be used for the treatment of mild to moderate COVID-19 in adults and certain pediatric patients who are at high risk of disease progression or hospitalization.
Please see the full
FDA statement.
REGEN-COV as well as bamlanivimab + etesevimab (administered together) continue to be available under EUA. There is no shortage of monoclonal antibody product. Sites that are administering COVID-19 monoclonal antibodies can continue to order bamlanivimab and etesevimab, etesevimab to pair with the current supply of bamlanivimab that the site has available, or REGEN-COV from the authorized distributer using the monitored direct ordering process.
ASPR will continue to work with our Federal partners on COVID-19 monoclonal antibody therapies authorized for emergency use and will provide updates as they become available.
Please contact
COVID19Therapeutics@hhs.gov with any questions.
